Assessing three day pentamidine for early stage human African trypanosomiasis (Angola)

ISRCTN ISRCTN35617647
DOI https://doi.org/10.1186/ISRCTN35617647
Secondary identifying numbers A30765
Submission date
15/04/2005
Registration date
07/06/2005
Last edited
06/12/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email gomesm@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPharmacokinetic studies have shown that pentamidine has a large volume of distribution and elimination occurs over a long period. The objective of the study is to assess the efficacy of 3 days Intramuscular (IM) pentamidine treatment compared to the standard 7 days IM pentamidine treatment regimen.
Ethics approval(s)Ethics approval received from:
1. World Health Organization (WHO)/Ethics Review Committee (ERC) on the 4th December 2003
2. Instituto de Combate e Control o Das Triponosommiases (ICCT) (Angola) on the 18th October 2004
3. Wandsworth Local Research Ethics Committee (UK) on the 3rd December 2003
Health condition(s) or problem(s) studiedHuman African Trypanosomiasis (HAT)
InterventionThis will be an open, randomised comparison of two pentamidine treatment regimens, given over three days or seven days with a non-inferiority trial design.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Pentamidine
Primary outcome measureProportion of cases with favourable progress at 6 months, based on clinical state and laboratory status.
Secondary outcome measures1. Proportion of cases with favourable progress at discharge, 3 and 12 months based on clinical state and laboratory status
2. Cure rate at 18 months, based on based on clinical state and laboratory status
3. Frequency and severity of adverse events
Overall study start date20/12/2004
Completion date20/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsThe total target was 440 patients, but only 18 were recruited in this site.
Key inclusion criteria1. Aged more than or equal to 14 years and less than 60 years
2. Parasite positive (on examination of lymph juice, by Capillary Tube Centrifugation [CTC] or miniature Anion-Exchange Centrifugation [mAEC] on whole blood)
3. Alternative diagnoses excluded clinically and by appropriate laboratory investigations
4. Capable of and giving informed consent to the study
Key exclusion criteria1. Stage II Human African Trypanosomiasis (HAT): defined as parasites in cerebrospinal fluid (CSF), or having more than or equal to 6 cells/mm^3 in CSF; or more than 100 red cells/mm^3 ("bloody tap")
2. Pregnant
3. Previous HAT
4. Known allergy or reactions to pentamidine
5. Diabetes mellitus
6. Difficulty to comply with follow-up (patients of no fixed abode and refugees, for example)
Date of first enrolment20/12/2004
Date of final enrolment20/12/2006

Locations

Countries of recruitment

  • Angola
  • Switzerland

Study participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Other

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan